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Fetal Growth Retardation clinical trials

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NCT ID: NCT02672566 Completed - Clinical trials for Fetal Growth Retardation

Low-molecular-weight Heparin in Constituted Vascular Intrauterine Growth Restriction

GROWTH
Start date: July 22, 2016
Phase: Phase 3
Study type: Interventional

Intrauterine growth restriction (IUGR) is correlated to an abnormal placenta development, with an alteration of the maternal-fetal circulation, coagulation troubles, and apparition of placental infarcts. IUGR represents the third cause of perinatal mortality in France, and is associated to an important morbidity. For birth-weights < 10th percentile of the gestational age, the neonatal death risk is doubled, compared to abnormal weights. In 35% of cases, IUGR is of vascular origin and is included in the broader framework of placental vascular pathology (PVP). Up to now, studies have focused on the primary or secondary prevention of PVP. Few studies have evaluated the treatment of constituted vascular IUGR. Currently, the management of vascular IUGR is mainly based on active surveillance, or termination of pregnancy. Pathological findings suggest that placental pro-thrombotic phenomena play a role in the constitution of vascular IUGR. Since aspirin is not effective in reducing this type of event, a randomized, open-label study conducted in China compared 14-day treatment with low-molecular-weight heparin (LMWH) versus Dan-Shen (a product not used in France) after diagnosis of IUGR. This trial, including 73 patients, showed a significant improvement in average growth kinetics in the LMWH group. The mean birth weight was 2877 g in the heparin group and 2492 g in the Dan-Shen group (p <0.0001). However, no data were provided concerning the number of newborns with a birth weight <10th percentile, i.e. the risk of morbidity and mortality, or complications occurring. Due to the lack of reliable data, LMWH are not included in the currently recommended therapeutic strategy for vascular IUGR. The studies in IUGR reported to date mainly focused on primary or secondary prevention in women at risk of PVP, assessing the value of aspirin, which showed only a modest effect. No effective therapeutic strategy is available to treat patients with constituted vascular IUGR, a situation where LMWH should be more effective than antiplatelets given the vascular context.

NCT ID: NCT02596594 Completed - Clinical trials for Intrauterine Growth Restriction

Intraumbilical Amino Acids and Glucose Supplementation Via Port by Severe IUGR in Human Fetuses

port-IUGR
Start date: January 2010
Phase: N/A
Study type: Interventional

Placental insufficiency is responsible for fetal loss in about 40% of all stillbirths and long term neurological deficits. The mean interval from diagnosis of brain sparing of severe IUGR fetuses to delivery has been recently identified by only seven days (Flood K et al, Am J Obstetrics and Gynecology 2014). The critical placental player in the active amino acids (AA) transport from the mother to the fetus is the trophoblast, which is irreversibly changed in severe IUGR fetuses caused by placental insufficiency. Thus, a logical partial solution of IUGR could be the direct supply of AAs and glucose to the fetus, in order to improve the fetal growth, normalize the fetal programming and to prolong the pregnancy. The aim of this prospective pilot study is to further test the efficacy of the administration of AAs and glucose supplementation with hyperbaric oxygenation (HBO), via a subcutaneously implanted intraumbilical perinatal port system, as a treatment option for severe IUGR human fetuses with brain sparing.

NCT ID: NCT02590536 Completed - Clinical trials for Fetal Growth Retardation

A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction

Start date: October 2015
Phase: Phase 3
Study type: Interventional

This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler velocity indices of the umbilical arteries in patients with placental insufficiency and fetal growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those patients.

NCT ID: NCT02583763 Active, not recruiting - Clinical trials for Fetal Growth Retardation

Cardiac Displacement From Third Trimester to Early Childhood

CADETTE
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

The aim is to increase awareness of the relationship between (IUGR) and cardiac function in the foetus, the development of cardiac function over time after delivery and what significance a possible early disturbed myocardial function have for the neonate and the child during the first years of life.

NCT ID: NCT02541110 Not yet recruiting - Preeclampsia Clinical Trials

Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler

Start date: September 2015
Phase: N/A
Study type: Observational

Second trimester homocysteine & uterine artery doppler will be assessed& the cases will be followed up till delivery for development of preeclampsia, IUGR(intra-uterine growth retardation) & other obstetric complications.

NCT ID: NCT02523222 Completed - Hypoglycemia Clinical Trials

Prophylactic Dextrose Gel for Newborns at High-risk for Hypoglycemia

Start date: July 2016
Phase: N/A
Study type: Interventional

This will be a quasi-experimental study comparing blood glucose values 30 minutes after feeding alone or feeding + 40% dextrose gel in newborns at risk for transient neonatal hypoglycemia.

NCT ID: NCT02518126 Not yet recruiting - Clinical trials for to Compare LIF Level in Cord Blood of Embryo's That Are IUGR to Those That Are AGA

Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

Start date: August 2015
Phase: N/A
Study type: Observational

To see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses

NCT ID: NCT02515292 Recruiting - Clinical trials for Intrauterine Growth Restriction

Evaluation of Infants With Intrauterine Growth Restriction

ModeInfIUGR
Start date: June 2014
Phase: N/A
Study type: Observational

Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical model . Objectives: 1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor gene expression in cord blood from newborns with intrauterine growth restriction (IUGR). (Prospective) 2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective & prospective) 3. Evaluation and monitoring of morphological and functional by echocardiography. (Prospective) 4. Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.

NCT ID: NCT02473991 Recruiting - Pregnancy Clinical Trials

Correlation Between Placental Thickness in the Second and Third Trimester and Fetal Weight

Start date: March 2015
Phase: N/A
Study type: Observational

The aim of this prospective longitudinal study was to investigate the relationship between placental thickness during the second and third trimesters and placental and birth weights.

NCT ID: NCT02442492 Terminated - Clinical trials for Intrauterine Growth Restriction (IUGR)

Sildenafil Therapy In Dismal Prognosis Early-Onset Intrauterine Growth Restriction

STRIDERCan
Start date: January 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Early-onset placental intrauterine growth restriction (EO IUGR) is associated with a high risk of perinatal morbidity and mortality. In association with reduced circulating placental growth factor (PlGF) EO IUGR results from abnormal placentation with inadequate remodelling of the maternal uteroplacental arteries. There is no known treatment for placental IUGR. Management involves intensive fetal surveillance with delivery with evidence of serious fetal compromise. However, remote from term, delivery is associated with significant perinatal mortality and morbidity. Sildenafil vasodilates the uteroplacental vessels of IUGR-affected pregnancies and may represent a novel therapy.